FORZINITY
- Product NDC
- 72507-800
- 11-digit product format
- 725070800
- Labeler code
- 72507
- Product ID
- 72507-800_459e2433-fbbb-2cef-e063-6394a90a81fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Elamipretide Hydrochloride
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Stealth Biotherapeutics Inc.
- Application
- NDA215244
- Marketing category
- NDA
- Marketing start
- 2025-10-30
- Substance
- ELAMIPRETIDE HYDROCHLORIDE
- Active strength
- 280 mg/3.5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FORZINITY
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ELAMIPRETIDE HYDROCHLORIDE | 280 mg/3.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | E40WZ3BK2D |
| Rxcui | 2725604, 2725610 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72507-800-04 | FORZINITY | 4 in 1 CARTON | INJECTION | 4 | | 10 |
| 72507-800-30 | FORZINITY | 3.5 mL in 1 VIAL | INJECTION | 3.5 | | 10 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72507-800-04 | 72507080004 | 4 VIAL in 1 CARTON (72507-800-04) / 3.5 mL in 1 VIAL (72507-800-30) | 4 vial | 2025-10-30 | No | No | Historical |
| 72507-800-30 | 72507080030 | 3.5 mL in 1 VIAL | 3.5 ml | | | | Historical |